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Active Not Recruiting NCT04795934

Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

Conditions: GERD, Hiatal Hernia

Sex: All
Ages: 22 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 142
Sponsor: Mayo Clinic

Location: University of California Irvine Irvine California

Summary

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.

Eligibility Criteria

Inclusion Criteria: 1. 22-80 years of age 2. Subjects have GERD with hiatal hernia \< 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV 3. Pathologic reflux while off PPI based on Lyon criteria by either of the following: 3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis. 3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B. 4. Commitment to long-term study 5. Ability to give consent individually or by a legally authorized representative Exclusion Criteria: 1. Hiatal hernia \> 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) 2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator 3. Pregnancy (in females) at time of procedure 4. Previous anti-reflux procedure 5. Subjects requiring mesh treatment at time of procedure 6. At the discretion of the site PI for subject safety 7. BMI \> 35 at time of surgery. 8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty. 9. Severe gastroparesis

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04795934). StuddyBuddy aggregates publicly available trial information.